KalVista's Sebetralstat NDA Accepted by FDA, Could Be First Oral On-Demand HAE Treatment by Mid-2025
Portfolio Pulse from Benzinga Newsdesk
KalVista Pharmaceuticals' NDA for sebetralstat, an oral treatment for hereditary angioedema, has been accepted by the FDA. If approved, it could become the first oral on-demand treatment for HAE by mid-2025.
September 03, 2024 | 10:32 am
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
KalVista Pharmaceuticals' NDA for sebetralstat has been accepted by the FDA, with a decision expected by June 2025. This could lead to the first oral on-demand treatment for HAE, potentially boosting the company's market position.
The acceptance of the NDA by the FDA is a significant milestone for KalVista, indicating progress towards approval. If approved, sebetralstat would be the first oral treatment for HAE, potentially increasing market share and revenue for KalVista. The lack of an advisory committee meeting suggests a smoother approval process, which is positive for the stock.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100